UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006692 |
|---|---|
| Receipt number | R000007911 |
| Scientific Title | Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2017/11/13 08:40:46 |
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Basic information
Public title
Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Acronym
Gene expression analysis of pulmonary fibrosis and emphysema
Scientific Title
Analysis of susceptibility moleculde for idiopahtic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD)
Scientific Title:Acronym
Gene expression analysis of pulmonary fibrosis and emphysema
Region
| Japan |
Condition
Condition
idiopatic pulmonary fibrosis
chronic obstructive lung disease
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the molecules relating to the development of pulmonary fibrosis and emphysema by accomplishing comprehensive gene expression analysis of fibrotic and emphysematous lung tissue.
Basic objectives2
Others
Basic objectives -Others
Lung tissue without lung cancer obtained by surgical resection of lung cancer will be used. Lung tissue from patients with pulmonary fibrosis, emphysema and without these changes will be afforded to comprehensive gene expression analysis. Difference in gene expression will be analyzed to find out important molecules for pulmonary fibrosis and emphysema.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in gene expression between the lung tissue from the patient with pulmonary fibrosis, emphysema and without these.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
In the case who recieved surgical resection of lung cancer, who have pumonary fibrosis or emphysema or normal lung
Key exclusion criteria
The cases with lung disases other than pumonary fibrosis and emphysema
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Munakata |
Organization
Fukusima Medical University
Division name
Department of Pulmonary Medicine
Zip code
Address
Hikarigaoka-1, Fukusima City
TEL
024-547-1360
munakata@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuru Munakata |
Organization
Fukusima Medical University
Division name
Department of Pulmonary Medicine
Zip code
Address
Hikarigaoka-1, Fukusima City
TEL
024-547-1360
Homepage URL
munakata@fmu.ac.jp
Sponsor or person
Institute
Fukusima Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Retrospective, case-control study to eluciddate characteristically expressed molelules for pulmonary fibrosis and emphysema
Management information
Registered date
| 2011 | Year | 11 | Month | 08 | Day |
Last modified on
| 2017 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007911
